QA Engineer

SCOPE & RESPONSIBILITIES

Manage ECOs: conduct risk assessment, update relevant DMR documents and carry out 

necessary IQ, OQ, PQ activities if required, finalization of implementation tasks

Manage DCOs in the PLM system: Write and update QA procedures to ensure compliance 

with quality standards and regulatory requirements

 Manage NCR and CAPA processes: Lead, write and supervise the NCR and CAPA 

processes, ensuring timely and effective resolutions

 Manage QA production activities: Provide quality support to production operations

addressing deviations and non-conformities to maintain high product quality

 Ensuring Timely Resolution of Quality Issues: Promptly address all identified or assigned 

quality issues to prevent delays and maintain efficient operations

 Participate in audits: Take part in internal and external audits, such as FDA inspections and 

notified body audits based on ISO13485, EUMDR, and MDSAP requirements

REQUIREMENTS

Bachelor of Science degree or Engineering

 2-5 years of experience in medical device QA (ISO 13485, FDA QSR 820)

Internal auditor certification- an advantage

 Ability to work in dynamic and multi-interfaced surroundings, micro and macro vision

Strong attention to details and Self-learning ability

 Ability to manage time and priorities and work under pressure

 English - high level (both written and spoken)

 Excellent leadership and people management skills

Service oriented

 Knowledge and practical experience in Priority – An advantage